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Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).
Schneider, Ruth B; Omberg, Larsson; Macklin, Eric A; Daeschler, Margaret; Bataille, Lauren; Anthwal, Shalini; Myers, Taylor L; Baloga, Elizabeth; Duquette, Sidney; Snyder, Phil; Amodeo, Katherine; Tarolli, Christopher G; Adams, Jamie L; Callahan, Katherine F; Gottesman, Joshua; Kopil, Catherine M; Lungu, Codrin; Ascherio, Alberto; Beck, James C; Biglan, Kevin; Espay, Alberto J; Tanner, Caroline; Oakes, David; Shoulson, Ira; Novak, Dan; Kayson, Elise; Ray Dorsey, Earl; Mangravite, Lara; Schwarzschild, Michael A; Simuni, Tanya.
  • Schneider RB; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Omberg L; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Macklin EA; Sage Bionetworks, Seattle, Washington, USA.
  • Daeschler M; Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Bataille L; Harvard Medical School, Boston, Massachusetts, USA.
  • Anthwal S; The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
  • Myers TL; The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
  • Baloga E; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Duquette S; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Snyder P; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Amodeo K; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Tarolli CG; Sage Bionetworks, Seattle, Washington, USA.
  • Adams JL; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Callahan KF; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Gottesman J; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Kopil CM; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Lungu C; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
  • Ascherio A; Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Beck JC; The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
  • Biglan K; The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
  • Espay AJ; Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.
  • Tanner C; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Oakes D; Parkinson's Foundation, New York, New York, USA.
  • Shoulson I; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Novak D; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Kayson E; Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
  • Ray Dorsey E; Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.
  • Mangravite L; Department of Biostatistics, University of Rochester Medical Center, Rochester, New York, USA.
  • Schwarzschild MA; Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
  • Simuni T; Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
Ann Clin Transl Neurol ; 8(2): 308-320, 2021 02.
Article in English | MEDLINE | ID: covidwho-985903
ABSTRACT

OBJECTIVE:

The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site-centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID-19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow-up of clinical trial participants, (2) compare changes in smartphone-based assessments, online patient-reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression.

METHODS:

Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT-HOME PD), a two-year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone-based assessments of motor function and socialization, and patient-reported outcomes online.

RESULTS:

From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient-reported outcomes on the online platform.

INTERPRETATION:

It is feasible to conduct a large-scale, international virtual observational study following the completion of participation in brick-and-mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow-up of clinical trial participants and design of future clinical trials.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Parkinson Disease / Research Design / Telemedicine / Videoconferencing / Mobile Applications / Smartphone / Patient Reported Outcome Measures Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Ann Clin Transl Neurol Year: 2021 Document Type: Article Affiliation country: Acn3.51236

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Parkinson Disease / Research Design / Telemedicine / Videoconferencing / Mobile Applications / Smartphone / Patient Reported Outcome Measures Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Ann Clin Transl Neurol Year: 2021 Document Type: Article Affiliation country: Acn3.51236